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Posts Tagged ‘Actos’

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group

Wolfe

By failing to ban the dangerous diabetes drug, Avandia, generic name rosiglitazone, the Food and Drug Administration (FDA) again caved to industry pressure. Although the FDA has made progress highlighting the risks of using Avandia by severely restricting the drug, it did not go far enough. Too many people could still be exposed to this dangerous product. Rather, the FDA should have acted with its European counterpart and outright banned Avandia from the market.

Why did it take the FDA so long to decide that a drug with no evidence of any advantage in health benefits, but abundant evidence of a variety of risks compared to other diabetes drugs, should be severely restricted? Why did it not ban this unsafe product?

More than three years ago at an FDA advisory committee meeting, Public Citizen urged the FDA to ban Avandia. Since then, 9 million prescriptions for the drug have been filled in the United States. This means that, just in the past three years alone, tens of thousands more patients have needlessly suffered hospitalizations for heart failure or deaths than would have had they taken Actos, a comparable, but safer drug.

There is not a single study finding that Avandia is safer than Actos, but there are numerous studies finding that Avandia is more dangerous than Actos. The FDA and GlaxoSmithKline have acted recklessly in allowing Avandia to stay on the market for so long after its unique dangers have been known.

The FDA should reconsider its decision to merely restrict such a hazardous product and directly remove it from the market.

Public Citizen petitioned the FDA in 2008 to ban Avandia.

Click here to learn more about Public Citizen’s work on Avandia.

Dr. Sidney Wolfe is the director of Public Citizen’s Health Research Group.

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Tomorrow, our own Sid Wolfe will be testifying before an FDA advisory committee about the much talked about diabetes drug Avandia, manufactured by drug maker GlaxoSmithKline.  The New York Times reported today that GlaxoSmithKline hid data indicating Avandia’s adverse effects for 11 years. The New York Times also explained the history of this dangerous drug.

In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.

But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.

Excuse our impatience, but we’ve been warning about Avandia for a decade. We petitioned the Food and Drug Administration to ban Avandia (also known as Rosiglitazone) back in 2000. Sid Wolfe has been saying all the things “recently uncovered” for years. It finally looks like something might happen though; the FDA is meeting to discuss Avandia today.

Check out Public Citizen’s history advocating for the removal of Avandia from store shelves.

You should also look at worstpills.org, our comprehensive fact-check website for all sorts of medications.

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We’ve written about the dangers of the diabetes drug Avandia and have told Congress about an unethical international clinical trial, requested by the FDA, being performed by Avandia’s manufacturer, GlaxoSmithKline.

Now Public Citizen and Canadian researcher/physician David Juurlink go straight to the source, sending a letter to FDA Commissioner Margaret Hamburg asking her to halt the study, which pits Avandia against its competitor, Actos.

From the Reuters story:

“A wealth of data now suggests” that Avandia carries greater risks than Actos, the researchers said. Patients are also not adequately informed about the safety differences between the two medicines when deciding whether to participate in the trial, they added.

But FDA officials, who have said they are already taking a closer look at Avandia, are not likely to act so quickly.

And the Los Angeles Times:

In act, both drugs [Avandia and Actos] have been tagged with safety issues: In addition to raising rates of cardiovascular events, the class of Type 2 diabetes drugs known as thiazolidinediones (or TZDs) have been linked in studies to higher rates of edema, macular edema, bony fractures, anemia and acute liver injury. Older diabetes medicine such as metformin and sulfonylurea are widely believed to be safer alternatives.

But to no avail — the FDA likely won’t examine the study until July, FiercePharma reports.

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